OBJECTIVE To investigate the
bioequivalence of
risperidone tablets in healthy volunteers.METHODS 2 mg reference or test tablets were given to 22 healthy male volunteers in a randomized two-way crossover design.The concentrations of risperidone and
9-hydroxy-risperidone were determined by HPLC/MS.The bioequivalence of two formulations were investigated by the analysis of variance,two one side t-test and 90% confidence interval test.RESULTS The pharmacokinetic parameters of risperidone reference and test tablets were as follows:AUC_(0-t)(124.80±116.22) and(137.19±118.12) μg·h·L~(-1),ρ_(max)(17.00±6.87) and(19.24±7.63) μg·L~(-1),t_(max)(1.52±0.93) and(1.32±0.58) h,K_e(0.19±0.13) and(0.18±0.12) h~(-1),t_(1/2K_e)(7.58±8.72) and(6.31±4.65) h.The pharmacokinitic parameters of 9-hydroxy-risperidone were as follows:AUC_(0-t)(564.3±182.42) and(580.01±205.38) μg·h·L~(-1),ρ_(max)(20.00±9.84) and(20.05±10.38) μg·L~(-1),t_(max)(5.93±3.59) and(5.70±3.18) h,K_e(0.032±0.007 8) and(0.034±0.008 0) h~(-1),t_(1/2K_e)(23.15±6.07) and(21.50±4.62) h.The pharmacokinitic parameters of total active moiety were as follows:AUC_(0-t)(692.54±235.57) and(720.80±260.22) μg·h·L~(-1),ρ_(max)(32.00±9.42) and(33.89±13.02) μg·L~(-1),t_(max)(2.27±1.50) and(1.98±1.25) h,K_e(0.033±0.008 6) and(0.035±0.007 8) h~(-1),t_(1/2K_e)(22.72±6.94) and(20.98±4.34) h,respectively.The mean relative bioavailability of tested vs reference tablets were(113.4±25.85)%,(104.6±20.83)%,(105.4±19.64)% for risperidone,9-hydroxy-risperidone and total active moiety respectively.CONCLUSION The two formulations are bioequivalent.
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